Events

Retiro De Equipo O Alerta De Seguridad para Ultrasound intravascular Volcano systems with accessories: catheters and accessories for imaging systems for intravascular ultrasound and pressure control Volcano s5 and Volcano s5i: device for pulling a single-use catheter Trackback II: 91003

Según Ministry of Health of the Republic of Belarus, este evento ( retiro de equipo o alerta de seguridad ) involucró a un dispositivo médico en Belarus que fue producido por Volcano Corporation, USA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    ИМ-7.99871
  • Fecha
    2014-01-10
  • País del evento
    Belarus
  • Fuente del evento
    MHRB
  • URL de la fuente del evento
    https://www.rceth.by/ru/Safety/MedSafety
  • Notas / Alertas
    Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
  • Notas adicionales en la data
  • Causa
    Volcano corporation has initiated a voluntary recall of all lots of the device for pulling a single-use catheter trackback ii: code 91003. the trackback ii is intended for use with eagle eye® intravascular imaging catheters. the device provides stable and accurate movement of the catheter, which allows you to evenly collect image data. the recall is initiated by the company as a precautionary measure due to concerns about the integrity of the primary packaging, which may affect the sterility of the product after shipment. volcano corporation has not received any complaints about this and no reports of harm to the patient or his death caused by the use of the product. however, the company asks to immediately stop using the device in trackback ii and return unused devices to the distributor.

Device

Ultrasound intravascular Volcano systems with accessories: catheters and accessories for imaging ...

Manufacturer

Volcano Corporation, USA
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    MHRB